I am sorry but I don’t know how they justified a

I am sorry but I don’t know how they justified all the numbers of patients .,
I will like to think that knowing how safe this drug is and results are good with EIND patients , they just wanted to help more patients .,
Is that possible ???

But I really don’t understand many things FDA require ,,
Generally the most important for them are
— side effects
And then
— efficacy

But knowing how good safety and efficacy we have with combo , but we still not approve as patients are dying .,,

So who can understand ???


All imo